FDA to miss third deadline on BPA ruling

Warning: Chemicals in the packaging, surfaces or contents of many products may cause long-term health effects, including cancers of the breast, brain and testicles; lowered sperm counts, early puberty and other reproductive system defects; diabetes; attention deficit disorder, asthma and autism. A decade ago, the government promised to test these chemicals. It still hasn't.

The U.S. Food and Drug Administration will miss its third self-imposed deadline on letting consumers know whether it is safe to use products made with bisphenol A, a chemical ingredient in the lining of most food and beverage cans.

FDA spokesman Michael Herndon said Tuesday the agency would not be making a decision before the end of the year, a pledge it made when it missed its Nov. 30 deadline.

The repeated delays have angered health advocates who consider the chemical a threat to human health.

"I'm extremely frustrated by the FDA delay, and I'm even more frustrated by their silence about the delay," said Janet Nudelman, policy director at the Breast Cancer Fund. "Each day it further delays taking action, more newborn babies, children and pregnant women are left unprotected from this hormone-disrupting compound linked to breast cancer and birth defects."

Alex Formuzis, spokesman at the Environmental Working Group, a health advocacy organization that has conducted several tests to measure consumer exposure to BPA, said evidence of the chemical's risks is "overwhelming."

"We believe it's time to act," he said.

Lobbyists for the chemical industry Tuesday declined to comment.

The chemical, which is found in 93% of Americans tested, and 90% of newborns, is believed to interrupt the body's endocrine system, even at extremely low doses.

Studies have linked BPA to cell changes that lead to breast and testicular cancer, obesity, sexual dysfunction, neural and behavioral problems, diabetes and heart disease.

In August 2008, FDA scientists declared BPA safe for all uses, a ruling that contradicted a finding by the National Toxicology Program. Scientists for that agency found cause for concern.

The Journal Sentinel reviewed e-mails between FDA scientists and chemical industry lobbyists and found that the agency allowed the chemical-makers to write entire sections of the FDA opinion. The FDA decision was based on two studies, both of which had been paid for by BPA-makers.

The FDA's own science board later found the agency wrongly ignored studies that found harm. It recommended that the agency review again the chemical's safety.

In congressional testimony June 3, FDA director Margaret Hamburg said she takes concerns about BPA very seriously and promised that the agency would take a "fresh look" at the science surrounding BPA. A decision would be made by early fall, she said.

The agency later postponed that decision until Nov. 30.

On Nov. 30, Herndon, the FDA spokesman, said the agency would have an announcement "very soon." When told at the time that health advocates were frustrated at the delay, Herndon said: "We are pushing hard for some decision soon - too soon for anyone to be frustrated."

At the time, he said it would come before the end of 2009.

Since then, Herndon has said only that no announcement will be made this week.

He refused to answer questions Tuesday, including whether consumers should continue to assume that the chemical was safe for all use.

Experts sound warning

Dozens of scientists who have worked with the chemical have called on the FDA to ban it in food contact items. They are especially concerned about fetuses and newborns whose development is believed to be especially sensitive to the chemical's effects. BPA leaches into food and liquid when heated.

The chemical is used to make thousands of household items, including dental sealants, eyeglasses, water bottles, compact discs and tableware. Each year, more than 6 billion pounds of BPA are produced in the United States, representing more than $7 billion in sales.

BPA-makers maintain that the chemical is safe. But hundreds of studies over the past several years have found BPA to harm laboratory animals. Recently, studies have found problems in humans, too.

Various regulatory agencies have given conflicting signals on the chemical's safety, confusing consumers.

In October, the Obama administration announced it was dedicating $30 million to the National Institute of Environmental Health Sciences to study the effects of BPA

Linda Birnbaum, director of that agency, told the Journal Sentinel on Dec. 11 that people should avoid ingesting the chemical, especially pregnant women, babies and children.

She urged people to seek alternatives.

Asked if consumers should be worried about BPA, Birnbaum said, "Absolutely."

Birnbaum's remarks, which were widely publicized, have added a sense of urgency to the FDA's decision, health advocates say.

Canada banned BPA from baby bottles in 2008. Similar bans have passed in Minnesota, Connecticut, Chicago and some New York counties.

Bills are pending in Congress to ban BPA in food contact items. Last week, a number of legislators renewed their support for a ban.

About Meg Kissinger

Meg Kissinger is an investigative reporter for health and welfare. She was a 2009 Pulitzer Prize finalist for investigative reporting and is a two-time George Polk Award winner: 2013 for "Chronic Crisis" and 2009 for "Chemical Fallout."